The present invention relates to a medical device and system that can be used to evaluate bladder pressure in patients.
Abnormal urinary voiding patterns are very common worldwide, affecting both women and men. Just for incontinence alone, the World Health Organization estimates that there are 200 million men and women worldwide with symptoms of urinary incontinence. This condition affects the patient both physically and emotionally—affecting the patient's quality of life. It is predicted that urinary incontinence will affect an estimated 30 million American women of all ages. This condition can interfere with work, travel, recreation and sexual activities. Urinary incontinence is also associated with urinary tract infections, and scrotal, perineal, and labial ulcers. Male incontinence is most commonly caused by prostate enlargement and/or surgery. Female incontinence often results from stretching of the pelvic support structures during pregnancy and childbirth. Additional contributory factors include a history of hysterectomy and post menopause.
In both sexes, other contributing factors to urinary incontinence include obesity, cigarette smoking, pelvic radiation therapy, diabetes, Parkinson's disease, back injury, cerebral vascular accident, and dementia. There are a variety of treatment options for bladder control problems ranging from behavioral therapy, pelvic muscle exercises, biofeedback, bladder training, fluid/dietary modifications, medications, urethral devices, pelvic floor supporters, and surgical procedures, such as bladder suspensions, slings, and urethral bulking procedures. In relatively minor cases, satisfactory treatment may include the use of absorbent pads combined with strengthening exercises and behavior modification. Anti-spasmodic medications may be added to the multi-modality regimen for treatment. Surgery may become necessary if these combinations of non-invasive treatments are inadequate. Various numbers of surgical options are currently available with many surgeries reinforcing and supporting the bladder neck region, either with anterior suture support or posterior anchored suture or sling support. Other procedures available include surgical injections of urethral bulking materials or elements that mechanically close the urethral opening (i.e., inflatable balloons, clamps).
A significant number of people also suffer from urinary retention. Retention in men is primarily caused by enlarged prostate (benign prostatic hypertrophy) or prostate carcinoma. Urinary retention in women is subtler to diagnose and maybe a result of weak bladder muscles in the elderly population.
Many abnormal voiding patterns are much more complicated than incontinence or retention alone. These people suffer from a mixed picture of both incontinence and retention in various degrees.
In order to determine effective therapy for these various, abnormal, voiding patterns of incontinence and retention, a variety of diagnostics are now performed to measure the bladder pressure during bladder filling and voiding. These devices are commonly catheter-based systems that are inserted into the bladder and remain in place during the measurement (e.g., U.S. Pat. No. 5,433,216 to Sugrue et al. and U.S. Pat. No. 6,334,064 to Fiddian-Green et al.). The disadvantage of these catheter-based systems is that the patient is forced to undergo tests in a clinical setting. In addition, the large catheter size can lead to patient discomfort during the measurement. Patients are immobilized during the test since they are physically attached to the equipment and machinery.
Improving these diagnostic techniques can greatly improve effective treatment of the above-referenced bladder conditions. It is often difficult to obtain pressure readings under normal conditions using the currently available pressure sensing catheters. Given the limitations of current techniques to diagnose urinary problems, there is a need for a novel device, system and method that can simplify and improve the accuracy for diagnosis and treatment of urinary problems.